Device recall
Z-2144-2020: Extremities Item Number: 1)113954 Hybrid Glenoid Glenoid Base, 4 MM 2) XL-115366…
FDA device recall · Class II · Biomet, Inc.
Key facts
| Recall number (Z-number) | Z-2144-2020 |
|---|---|
| Recall event | 85524 |
| Product | Extremities Item Number: 1)113954 Hybrid Glenoid Glenoid Base, 4 MM 2) XL-115366 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 41 MM, Standard 3) XL-115364 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 36 MM, +3MM Standard Product Usage: is indicated for use in… |
| Product code | PHX |
| Recalling firm | Biomet, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 25, 2021 |
| 510(k) numbers | K080642 |
| FEI number | 1825034 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database